Thursday, August 29, 2013

Children's National to Issue Consensus Paper on Pediatric Surgical Innovation and Device Development

The Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Medical Center is facilitating an international consensus paper as an outcome of its first annual International Symposium on Pediatric Surgical Innovation, held in June to discuss the current status and challenges to pediatric surgical innovation and medical device development. The symposium included discussions such as strategies for seeking regulatory approval in the top three medical device markets – the United States, the European Union, and Japan.

Following the day-long symposium, the organizers held a closed session with key opinion leaders and speakers from the conference to begin the formation of the white paper, which will be published in the last quarter of 2013. This document will outline a consensus from world-renowned thought leaders on recommended priorities and changes to address current challenges and to speed advances in pediatric surgical innovation and device development.  The white paper will address the unique nature of innovation in pediatric surgery and device development, current regulatory pathways, economic models, ethical concerns specific to medical product development for the pediatric population, the impact of regulatory standards worldwide, and best practices that might be shared across different regions of the globe.

“Calls are growing, from around the world, for change that will spur innovation in surgery and medical device development for pediatrics,” said Peter Kim, MD, CM, PhD, Vice President of the Sheikh Zayed Institute for Pediatric Surgical Innovation. “This white paper will provide a consensus, from leaders across the many disciplines involved, on priorities and steps to address the clinical, technical, economic and regulatory requirements that can hinder progress, if not addressed strategically.”

Topics the white paper will address include the FDA’s 510(k) clearance process, which applies to most pediatric medical devices, based largely on equivalence to existing devices created for adults. The white paper will also discuss factors related to the small size and vulnerable nature of the pediatric population, which presents distinct challenges for surgeons, researchers, manufacturers, and regulators in device development for this population.

“We know that infants and children are not simply small adults—their physiology is different, and they experience rapid anatomical and physiological change,” said Mark Batshaw, MD, Executive Vice President, Chief Academic Officer, and Physician-in-Chief at Children’s National. “An improved regulatory framework for pediatric devices and surgical tools will reflect these substantial differences, keeping safety paramount while encouraging future innovation and investment.”

The Sheikh Zayed Institute symposium drew nearly 250 high-level participants, including representatives from the U.S. Food and Drug Administration, European Medicines Agency, Japan’s Pharmaceuticals and Medical Devices Agency, U.S. National Institutes of Health, American Academy of Pediatrics, American Pediatric Surgical Association, World Federation of Associations of Pediatric Surgeons, children’s hospitals, pediatric device consortia, device makers, and experts in intellectual property and regulatory science. Presentations from the Symposium can be viewed here.

Video highlights from the symposium:

Monday, August 12, 2013

New Prototype Robot Developed for Pediatric Shoulder and Hip Arthrography

American children ages 5-14 experience an average of one or more sports-related injuries per year, often involving internal derangement of shoulders, hips, wrists and other joints [1].  In such cases, arthrography can assess the condition of a joint, using imaging modalities such as computed tomography (CT) or magnetic resonance imaging (MRI). The modality of choice to diagnose soft-tissue injuries in children is magnetic resonance (MR) arthrography since it involves no radiation and provides higher soft-tissue contrast than CT imaging.

However, currently MR arthrography requires two separate stages: an intra-articular contrast injection guided by fluoroscopy or ultrasound, followed by an MRI. In typical interventions, the physician guides a needle using cross-sectional images, often requiring multiple passes to reach the target. In MRI-guided interventions, patient access can be difficult, especially in closed bore scanners. The inability to leverage the imaging capabilities of the MRI itself to guide the needle and the manual nature of needle placement lead to increased cost, anxiety and in some cases prolonged sedation time - especially for the youngest and most anxious patients.

To address these limitations, researchers and engineers in the Sheikh Zayed Institute are developing a novel, patient-mounted CT and MRI robotic system to provide better targeting, improve the clinical workflow and allow better access with the MRI scanner bore.

Developing equipment compatible with a high magnetic field is the major challenge for a robotic system in MRI-guided interventions, so as a first step the Sheikh Zayed team has developed a CT-compatible prototype for shoulder and hip arthrography for pediatric use. This small and lightweight robot uses adhesive tape and straps for stable attachment to the patient's body. During procedures, major portions of the robot can be covered with sterile plastic sheets, and the remaining parts can manufactured to be disposable or to be sterilized for re-use.

Solidworks 3D model of the final design.

Final design.

The robot will connect to a computer through a Galil motor controller. Software—a dialog-based MFC application in Visual C++ on the Windows operating system—will convert input from the user interface devices into control signals to drive the robotic mechanism.
The prototype has three degrees of freedom for needle guidance and insertion. Two possible approaches will be tested for guiding the robot: 1) the physician controls the robot from the MRI control room with a joystick; or 2) the robot pre-aligns its trajectory to a commanded path on the MRI images and an indication from the physician of the target, and the physician manually drives the needle to the target while the robot maintains the trajectory.

With the initial design and prototype completed, the next step is to demonstrate the workflow and targeting capability in the CT environment. Ultimately, the team plans to develop an MRI-compatible robot capable of automatically driving a needle and injecting contrast material during a real-time MRI sequence to observe joint function and make an accurate diagnosis, shortening and streamlining procedure times for children.

[1] Shital Parikh, “The Trend of Pediatric Sports and Recreational Injuries in the U.S. in the Last Decade”, American Academy of Orthopaedic Surgeons's (AAOS) Anual meeting, 2013.

Posted on behalf of Kevin Cleary, PhD

Monday, August 5, 2013

Ramadan Reflections

As we enter the last week of Ramadan (August 7th), we asked several women from the UAE studying with us here at the Sheikh Zayed Institute, two members from the Student Innovators Program, and one, a pediatric resident, to share their thoughts on Ramadan and what this special time of year means to them.

Noura Al Dhaheri, Children's National Pediatric Resident, from Al Ain, UAE

Ramadan is a special time of the year when Muslims around the world take a step back from their daily routines and focus on community, charity, fasting, and prayer. Muslims use this month to re-evaluate their lives - make peace with those who have wronged them, strengthen ties with family and friends, and do away with bad habits.

As Ramadan helps us to develop our moral discipline, it also reminds us of the plight of those who live in constant hunger and deprivation. We are reminded by the revealed book (Qur'an) that religiosity is insincere and meaningless if it does not lead people to care and share. We are also told in the Qur'an that we will not attain righteousness until we spend of what we love. In other words, we must learn to empathize with the hungry and needy people and be willing to part with some of our dearest possessions, for the sake of others.

Ramadan is a great opportunity to share Islam's values of spirituality, generosity, and kindness with others, especially your neighbors.

Shatha Al Wahhabi, Sheikh Zayed Institute Student Innovator & Junior at Khalifa University

Charity plays an important role in Islam throughout the year and especially during Ramadan. One of the simplest acts that I usually do in my daily life is helping others in opening the door. Also, I put a small container filled up with water beside the window or in the garden for the little birds, so they can drink from it. Every time I do something related to charity, I remember my father's saying: "Keep doing the best and the simplest deeds to help needed people. You do not realize how much they need it."

The desire of serving the community and helping others motivated me to be involved in biomedical engineering.  I believe deep inside myself that the key of your inner happiness depends on the number of smiles you have drawn upon others faces.

Eiman Hammoudi, Sheikh Zayed Institute Student Innovator & Junior at Khalifa University

Fasting during Ramadan makes us value the graces that we have, especially food and water and to feel the suffering of the unfortunate. I remember seeing a woman being interviewed on TV during Ramadan. She put a pot on a fire and started to move the spoon inside it, the sun was about to set and people started to get ready to have their breakfast. A TV anchor asked her about her living condition and what does she eats normally. She replied that she was doing really well and had everything she needed to live, that God had given her everything.

The anchor man was surprised about the reply, because the lady was living in a tent. Then, his eyes went toward the pot, and he jokingly said, "are you making us the breakfast?" She didn't reply. He looked inside the pot, and it was empty! He asked her what she was doing. She said: "I don't have anything to cook, and I started my fire because I know that God will take care of me and will not let me down."

It was one of the saddest scenes that I have ever seen. I believe that people were created to help and support each other. The fortunate must help those who are less fortunate, no matter of their race or religion.